Class 2 Device Recall Triathlon Femoral Distal Augment

• Date Initiated by Firm: August 19, 2019
• Create Date: September 27, 2019
• Recall Status: Terminated on May 06, 2020
• Recall Number: Z-2759-2019
• Recall Event ID: 83671
• 510(K)Number: K141056 K190991
• Product Classification: Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
• Product: TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB) Catalog # 5542-A-201 - Product Usage:
• Code Information: All lots with an expiration date on or before 31 June 2024. Lot # A3I7L A4A7B A4V7D A7G7H A7H4U A7L4V A7V3U A9X4S A9Y3V AAG7R ABU3Y AEE3A AEU9Y AGT4R AGV3S ALS3V AOG3T AOX9L ASD3T ATT7D AV34S AYA3B AZB4R AZE9G BAE4X BAX4A BBG4X BDR7T BDZ4D BE37Y BGE4V BHE7X BIG4L BR79T BRU7O BSR4R DFHS DFOR DGFY DGJN DNNS DPSK GEZU GFBA GFWO GGID GISR GITX GLDE GLEK GLFE GYKA GZYI GZZO HVFF HYZB HZAP HZFF HZRR IDGA IDXJ IEYN IJPT IKJU IRIK ISIR IULX IWXH IZXM JAAE JFWD JFYR JHWV JJDF JLGH JMEP JPFR JTXL JUEV KFSH KGWZ KIDM KIFY KION KJYX KMKE KPKD KWXS KZDA LARN LBMI MDIF MMUR S3O3 S3OP ST3Y STHI STUE TAOV TARO TGLR UDYZ UUZT UWHB VEU4 VJKA VJLN VVKR VVMJ VW4Y VYAY WHOP WINY WIVT WOOU WPGU WRZZ WVWK WVWL WXAC WXAF XBEL XBEM XDXI XDXJ XIAR XIAS XKLP XKLR XMXO XMXP XMXR XSFR XSFS XVMV XVMW XVNF XVNG XWVH XWVI XYUX XYVJ YA3U YAIL YAIM YCFT YCFV YFUX YFUY YGIC YGID YHLN YHLO
• Recalling Firm/ Manufacturer: Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2006
• For Additional Information Contact: Ms. Loriann Russo,; 201-831-5272
• Manufacturer Reason for Recall: Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
• FDA Determined Cause: Device Design
• Action: 1. Inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-877-551-7148 or email to strykerortho4636@stericycle.com. 5. Return all affected instruments available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 2144473
• Quantity in Commerce: 153 units
• Distribution: Worldwide distribution - US Nationwide distribution including the states of AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Honk Kong, India, Ireland, Iran, Italy, Israel, Japan, Kazakhstan, Korea, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and UK.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MBH; 510(K)s with Product Code = MBH